BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5MM TAP (CANNULATED)

    MDR report key: 3191459 · Received June 26, 2013

    Report

    Report Number
    1723170-2013-00478
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION PROVIDED IS THAT OF THE SITE REPRESENTATIVE INVOLVED, NOT A SURGICAL PATIENT. DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE AT THIS TIME. FOLLOW-UP REPORT FROM THE INVOLVED SITE REPRESENTATIVE FINDS THERE WAS NO MEDICAL INTERVENTION REQUIRED, THE WOUND WAS WASHED. THE WIRE USED TO ATTEMPT CLEANING THE TAP CAME OUT OF THE HIND END. SUSPECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT LISTED ON THE INITIAL 3500A WAS ALREADY REPORTED ON MDR 1723170-2013-00480. THEREFORE THE FOLLOWING FIELDS NEED CORRECTION: THERE WAS NO PATIENT INVOLVED WITH THIS CONCERN.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THEY WERE UNABLE TO REMOVE BONE FROM A 6.5 TAP AFTER AUTOCLAVE AND CLEANING. IN THE PROCESS A SITE REPRESENTATIVE, SURGICAL NEURO COORDINATOR, PUNCTURED THE FLESHY SIDE OF HIS LEFT HAND. THIS WAS IDENTIFIED OUTSIDE THE SURGICAL ARENA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289999 6.5MM TAP (CANNULATED) NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR